# K212545: FlexitSystem Knee osteotomy system

- Pathway: 510(k) (Traditional)
- Applicant: Neosteo
- Decided: Feb 11, 2022 after 183 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K014155 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100676: Synthes Tomofix (TM) Meial High Tibia Plate, Small, Synthes (Usa) (2010) Summary page 5.
- K041601: Surfix Knee Osteotomy System, Surfix Technologies (2004) Summary page 5.
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 5.
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 5.

## Indications for use
The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.

Source page: https://510kreport.com/device/K212545
Methodology: https://510kreport.com/methodology